Actively Recruiting
A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) to Determine the Feasibility and Safety of Intratumoral Injection With or Without Intramural Injection in Subjects With Bladder Cancer
Led by Aura Biosciences · Updated on 2026-04-15
55
Participants Needed
17
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility and safety of Belzupacap Sarotalocan (AU-011) treatment for bladder cancer, specifically non-muscle-invasive bladder cancer (NMIBC). This phase 1 open-label trial aims to assess the safety, technical feasibility, and initial effectiveness of AU-011 with minimal disruption to the standard treatment, transurethral resection of bladder tumor (TURBT). The study involves several treatment groups receiving different doses and methods of AU-011 administration. Treatments include intratumoral and intramural injections of AU-011, sometimes combined with laser application, before the standard TURBT procedure. Participants with intermediate or high-risk NMIBC will receive multiple cycles of focal AU-011 with laser activation, with some groups having the option or requirement of TURBT. Safety and response to treatment will be evaluated up to 12 months after starting treatment. Participants will undergo assessments for safety, including monitoring serious adverse events and dose-limiting toxicities for up to 12 months. Researchers will also measure treatment responses, such as complete response rates at 3 months and TURBT, duration of response up to 12 months, durable response rates at 6, 9, and 12 months, and recurrence-free survival over 12 months. The trial is designed to closely monitor participants while integrating the investigational treatment with current care practices.
CONDITIONS
Brief Title
A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathological diagnosis of non-muscle-invasive bladder cancer (NMIBC) of any grade.
- For first diagnosis NMIBC, recent biopsy within 6 months confirming urothelial carcinoma.
- For recurrent NMIBC, current lesion clinically appearing as NMIBC with confirmation by TURBT or biopsy within 24 months.
- Diagnosis of low-grade intermediate-risk NMIBC according to AUA guidelines for certain cohorts.
- Diagnosis of high-risk NMIBC according to AUA guidelines for certain cohorts.
- Participants may be BCG-naïve or previously treated with BCG except BCG-refractory.
- No evidence of current or prior metastatic urothelial carcinoma.
- Adequate bone marrow, kidney, and liver function.
You will not qualify if you...
- Any other active cancer requiring treatment unless approved by the Medical Monitor.
- Use of investigational drugs or devices within 30 days or 5 half-lives before enrollment or concurrent enrollment in another trial.
- Active bacterial, fungal, or viral infections.
- Active autoimmune or chronic inflammatory conditions requiring systemic immunosuppressants or steroids.
- Chronic active hepatitis B or C infections and HIV infection.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive focal injections of AU-011 with or without laser application, followed by optional or mandatory TURBT depending on the cohort. Multiple treatment cycles may occur for up to 12 months with evaluations for safety and response.
Multiple treatment visits over up to 12 months
Duration - Up to 12 months
Participants are monitored for safety, response duration, complete response, and recurrence-free survival after treatment ends.
Regular visits during follow-up for up to 12 months
Trial Site Locations
Total: 17 locations
1
Arkansas Urology
Little Rock, Arkansas, United States, 72211
Terminated
2
Tower Urology
Los Angeles, California, United States, 90048
Actively Recruiting
3
Saint John's Cancer Institute
Santa Monica, California, United States, 90404
Actively Recruiting
4
Montefiore Medical Center
The Bronx, New York, United States, 10461
Actively Recruiting
5
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29272
Actively Recruiting
6
Urology Associates, P.C.
Nashville, Tennessee, United States, 37209
Suspended
7
Urology Clinics of North Texas
Dallas, Texas, United States, 75251
Actively Recruiting
8
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
9
The University of Texas San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
10
Urology San Antonio/USA Clinical Trials
San Antonio, Texas, United States, 78229
Actively Recruiting
11
The Urology Place
San Antonio, Texas, United States, 78240
Actively Recruiting
12
Westmead Private Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
13
Austin Health
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
14
Warringal Private Hospital
Heidelberg, Victoria, Australia
Actively Recruiting
15
Penninsula Private Hospital
Langwarrin, Victoria, Australia, 3910
Not Yet Recruiting
16
The Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Not Yet Recruiting
17
Hollywood Private Hospital
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
Research Team
M
Medical Monitor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
10
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